Last updated on January 2019

Trial of Atezolizumab and Vigil for Advanced Gynecological Cancers (A Companion Study to CL-PTL-119)


Brief description of study

This is a crossover study of Vigil, Atezolizumab and their combination in patients who have tumor harvested at surgery and successful manufacturing of Vigil but are ineligible for CL-PTL-119 (the VITAL study) or previously randomized to placebo.

Detailed Study Description

This is a randomized, open label intra-patient crossover study of Vigil, the checkpoint inhibitor Atezolizumab and the combination of the two agents, in patients with epithelial ovarian cancer, or other gynecological cancers (i.e., cervical, uterine). Eligible patients will be randomized to receive two cycles of Vigil alone or two cycles of atezolizumab alone, followed by combination treatment with the two agents.

This study is intended as a companion study to protocol CL-PTL-119, A Randomized, Double Blind, Placebo Controlled Phase 3 trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy, otherwise known as the VITAL study. Patients who have tumor harvested at surgery and Vigil successfully manufactured, but then are ineligible for randomization onto the VITAL study or previously randomized to placebo, will be offered the opportunity to participate in this protocol.

Subjects enrolled will either be:

Patients with recurrent disease, undergoing a standard surgical procedure (e.g. surgical debulking, palliative resection, malignant ascites or others) will have tumor procured for manufacture of Vigil.

OR

  • Patients with ovarian cancer who failed to meet the eligibility criteria for Protocol CL-PTL-119 because of failure to achieve a complete clinical response following primary debulking surgery and standard paclitaxel/carboplatin therapy, OR
  • Patients who fail to meet the eligibility criteria for Protocol CL-PTL-119 because of a histologic diagnosis of another gynecological cancer (i.e., cervical, uterine) and not ovarian cancer.

OR

Patients who were randomized on Protocol CL-PTL 119 and were subsequently unblinded at recurrence and were assigned to the placebo arm.

Clinical Study Identifier: NCT03073525

Contact Investigators or Research Sites near you

Start Over

Rodney Rocconi, MD

University of South Alabama Mitchell Cancer Institute
Mobile, AL United States
1.7miles
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.